DDP Specialty Electronic Materials US 9, LLC
Form 483 issued November 7, 2018 · Hemlock, Michigan
- Observations
- 1
- Pages
- 2
- FEI number
- 1816403
In short: On November 7, 2018, FDA issued a Form 483 with 1 observation to DDP Specialty Electronic Materials US 9, LLC in Hemlock, Michigan (FEI 1816403). Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Original records are not reviewed for accuracy, completeness, and…
This inspection in context
Questions about this 483
What did FDA find at DDP Specialty Electronic Materials US 9, LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
When was DDP Specialty Electronic Materials US 9, LLC inspected by FDA?
This Form 483 is dated November 7, 2018.
How do I get the full Form 483 for DDP Specialty Electronic Materials US 9, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.